NCT02224248

Brief Summary

The purpose of this study is to investigate if including fitness testing in preventive health checks increase cardiorespiratory fitness and motivation to change physical activity behavior compared with preventive health checks without fitness testing.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,201

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 8, 2014

Completed
17 days until next milestone

First Posted

Study publicly available on registry

August 25, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

November 11, 2016

Status Verified

December 1, 2015

Enrollment Period

1.7 years

First QC Date

August 8, 2014

Last Update Submit

November 10, 2016

Conditions

Cardiorespiratory FitnessPhysical ActivityHealth BehaviorMotivationIntention

Keywords

cardiorespiratory fitnessexercise toleranceexercise testhealth behaviormotor activitymotivationintentionself-rated health

Outcome Measures

Primary Outcomes (1)

  • Cardiorespiratory fitness

    Mean cardiorespiratory fitness level and the percentage of participants with very low cardiorespiratory fitness level assessed at the one year follow up will be compared between the two study groups.

    One-year follow up

Secondary Outcomes (4)

  • Reported physical inactivity prevalence change

    Between baseline and the one-year follow up.

  • Self-rated general health change

    From baseline to the one-year follow up.

  • Self-rated physical health score change

    From baseline to the one-year follow up.

  • Self-rated mental health score change

    From baseline to the one-year follow up.

Other Outcomes (1)

  • Stages of Change for physical activity

    From baseline to an intermediate two-weeks follow up.

Study Arms (2)

Health checks with fitness testing

EXPERIMENTAL
Behavioral: Health checks with fitness testing

Health checks without fitness testing

ACTIVE COMPARATOR
Behavioral: Health checks without fitness testing

Interventions

Health checks with fitness testingBEHAVIORAL

Fitness testing as part of a preventive health check compose the intervention in this trial. Thus, the intervention group will receive preventive health checks with fitness testing.

Health checks with fitness testing
Health checks without fitness testingBEHAVIORAL

The active comparator will not receive fitness testing as part of the preventive health checks. With the exception of fitness testing, the preventive health checks in the active comparator group and the intervention group are identical.

Health checks without fitness testing

Eligibility Criteria

Age30 Years - 49 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Citizens in the municipality of Randers per 01.01.2012
  • Randomized for the third group of five to be invited for a preventive health check as part of the health promotion program, Check your health prevention program, conducted in the years 2012 to 2017.
  • Having received a preventive health check before November 30 2015.
  • Having consented for data to be used scientifically.

You may not qualify if:

  • Terminal illness as reported by the citizens general practitioner.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of public health, section of general practice, Aarhus University

Aarhus C, Aarhus County, 8000, Denmark

Location

Related Publications (12)

  • DISHMAN R, ICKES W, MORGAN W. Self-motivation and adherence to habitual physical-activity. J Appl Soc Psychol. 1980;10(2):115-132. doi: 10.1111/j.1559-1816.1980.tb00697.x.

    BACKGROUND

  • Dalton AR, Soljak M. The nationwide systematic prevention of cardiovascular disease: the UK's health check programme. J Ambul Care Manage. 2012 Jul-Sep;35(3):206-15. doi: 10.1097/JAC.0b013e318240be9d.

    PMID: 22668610BACKGROUND

  • Lauritzen T, Jensen MS, Thomsen JL, Christensen B, Engberg M. Health tests and health consultations reduced cardiovascular risk without psychological strain, increased healthcare utilization or increased costs. An overview of the results from a 5-year randomized trial in primary care. The Ebeltoft Health Promotion Project (EHPP). Scand J Public Health. 2008 Aug;36(6):650-61. doi: 10.1177/1403494807090165.

    PMID: 18775821BACKGROUND

  • Warburton DE, Nicol CW, Bredin SS. Health benefits of physical activity: the evidence. CMAJ. 2006 Mar 14;174(6):801-9. doi: 10.1503/cmaj.051351.

    PMID: 16534088BACKGROUND

  • Textbook of work physiology. Åstrand & Rodahl. 3rd ed. McGraw Hill 1986.

    BACKGROUND

  • Nigg CR. There is more to stages of exercise than just exercise. Exerc Sport Sci Rev. 2005 Jan;33(1):32-5.

    PMID: 15640718BACKGROUND

  • Saltin B, Grimby G. Physiological analysis of middle-aged and old former athletes. Comparison with still active athletes of the same ages. Circulation. 1968 Dec;38(6):1104-15. doi: 10.1161/01.cir.38.6.1104. No abstract available.

    PMID: 5721960BACKGROUND

  • Ware JE, Kosinski M, Turner-Bowker DM, Gandeck B, eds. User∩s manual for the SF-12v2TM health survey (with a supplement documenting the SF-12 health survey). Lincoln, RI: QualityMetric Incorporated, 2007; 2007.

    BACKGROUND

  • Waters L, Reeves M, Fjeldsoe B, Eakin E. Control group improvements in physical activity intervention trials and possible explanatory factors: a systematic review. J Phys Act Health. 2012 Aug;9(6):884-95. doi: 10.1123/jpah.9.6.884.

    PMID: 22898467BACKGROUND

  • Adams G, Gulliford MC, Ukoumunne OC, Eldridge S, Chinn S, Campbell MJ. Patterns of intra-cluster correlation from primary care research to inform study design and analysis. J Clin Epidemiol. 2004 Aug;57(8):785-94. doi: 10.1016/j.jclinepi.2003.12.013.

    PMID: 15485730BACKGROUND

  • Sterne JA, White IR, Carlin JB, Spratt M, Royston P, Kenward MG, Wood AM, Carpenter JR. Multiple imputation for missing data in epidemiological and clinical research: potential and pitfalls. BMJ. 2009 Jun 29;338:b2393. doi: 10.1136/bmj.b2393.

    PMID: 19564179BACKGROUND

  • Hoj K, Skriver MV, Hansen AL, Christensen B, Maindal HT, Sandbaek A. Effect of including fitness testing in preventive health checks on cardiorespiratory fitness and motivation: study protocol of a randomized controlled trial. BMC Public Health. 2014 Oct 10;14:1057. doi: 10.1186/1471-2458-14-1057.

    PMID: 25300392DERIVED

Related Links

MeSH Terms

Conditions

Motor ActivityHealth Behavior

Interventions

Exercise Test

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Heart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisRespiratory Function TestsDiagnostic Techniques, Respiratory SystemErgometryInvestigative Techniques

Study Officials

  • Annelli Sandbæk, Professor

    Institute of public health, section of general practice, Aarhus University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 8, 2014

First Posted

August 25, 2014

Study Start

October 1, 2014

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

November 11, 2016

Record last verified: 2015-12

Locations

DK(1)